LDR infant drops

Manufacturer
Cardinal Health | GCP Laboratories
Effective date
2021-07-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:41:22

Label at a glance#

ProductINFANTS GAS RELIEF
Active ingredientDIMETHICONE
Label structure8 sections

Dosage and administration

shake well before using all dosages may be repeated as needed, after meals and at bedtime, or as directed by a physician do not exceed 12 doses per day fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby’s mouth, toward inner cheek may be mixed with 1 oz of cool water, infant formula or other suitable liquid clean dropper well after each use and replace original cap Age (years) W...

Storage and handling

store at room temperature do not freeze see bottom panel for lot number and expiration date TAMPER-EVIDENT: Do not use if foil seal under cap is broken or missing

Label contents#

Full prescribing information#

Active ingredient (in each 0.3 mL)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 20 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Use

INDICATIONS & USAGE SECTION

relieves the symptoms referred to as gas

Warnings

WARNINGS SECTION


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before using
  • all dosages may be repeated as needed, after meals and at bedtime, or as directed by a physician
  • do not exceed 12 doses per day
  • fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby’s mouth, toward inner cheek
  • may be mixed with 1 oz of cool water, infant formula or other suitable liquid
  • clean dropper well after each use and replace original cap
Age (years)Weight (lbs) Dose
infants (under 2)under 240.3 mL
children (2 and over)24 and over0.6 mL

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature
  • do not freeze
  • see bottom panel for lot number and expiration date
  • TAMPER-EVIDENT: Do not use if foil seal under cap is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

carboxymethylcellulose sodium, citric acid, flavor, maltitol, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate, xanthan gum.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-540-3765

package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0423-1ML - Milliliter70000-0423806e8a8c-59ec-402b-85b5-f9691dab48f212019-08-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-042370000-0423-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
efb93c29-0b84-6a6f-e053-2a95a90a91d67ee32981-36dc-1930-e053-2991aa0a4c182022-12-13WarningsExact identifier
spl set id: 7ee32981-36dc-1930-e053-2991aa0a4c18

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.